Actively Recruiting

Phase 3
Age: 18Years +
All Genders
NCT06954155

Tenecteplase Reperfusion Therapy in Acute Ischemic Cerebrovascular Events-BEYOND

Led by Beijing Tiantan Hospital · Updated on 2026-04-01

330

Participants Needed

1

Research Sites

104 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

The benefit-risk profile of thrombolysis for acute ischemic strokes beyond 24 hours has never been investigated. We initiated a multicenter, prospective, randomized, open label, blinded-endpoint (PROBE) controlled trial to assess the safety and efficacy of tenecteplase (0.25mg/kg, max 25mg) versus standard medical treatment in acute ischemic stroke due to intracranial vessel occlusion between 24-72 hours of symptom onset (including wake-up stroke and unwitnessed stroke).

CONDITIONS

Official Title

Tenecteplase Reperfusion Therapy in Acute Ischemic Cerebrovascular Events-BEYOND

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Stroke symptom onset between 24 to 72 hours before enrollment, including wake-up and unwitnessed strokes
  • Pre-stroke modified Rankin Scale (mRS) score of 1 or less
  • Baseline NIH Stroke Scale (NIHSS) score between 6 and 25, or score of 4 or 5 with a disabling deficit such as hemianopia, aphasia, or loss of hand function
  • Confirmed occlusion of middle cerebral artery (M1-M4), anterior cerebral artery, posterior cerebral artery, or basilar artery by CTA/MRA causing stroke symptoms
  • Target mismatch profile on perfusion imaging (ischemic core volume less than 70 mL, mismatch ratio greater than 1.2, and mismatch volume greater than 10 mL)
  • Written informed consent from patient or legally authorized representative
Not Eligible

You will not qualify if you...

  • Significant low-density lesion on CT scan
  • Allergy to tenecteplase
  • Rapidly improving stroke symptoms
  • NIHSS consciousness score 1a greater than 2, epileptic seizure, Todd's palsy, or inability/unwillingness to cooperate
  • Persistently high blood pressure (systolic ≥185 mmHg or diastolic ≥110 mmHg) despite treatment
  • Blood glucose less than 2.8 or greater than 22.2 mmol/L
  • Active internal bleeding or high bleeding risk from recent surgery, trauma, hemorrhage, or arterial puncture
  • Known blood clotting problems or recent use of certain blood thinners without reversal
  • Platelet count below 100,000/mm3 or known platelet function defects
  • Recent ischemic stroke, heart attack, brain injury, brain surgery, or known brain abnormalities within 3 months
  • Terminal illness with life expectancy under 1 year
  • Unable to undergo perfusion imaging tests
  • Large brain area affected on CT scan (more than one-third of middle cerebral artery territory or low pc-ASPECTS score)
  • Acute or past brain hemorrhage on imaging
  • Multiple artery occlusions
  • Pregnancy, breastfeeding, or refusal to use contraception
  • Unlikely to follow study protocol or attend follow-ups
  • Any condition judged by investigator to pose hazards or affect participation
  • Participation in other interventional clinical trials within past 3 months

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

Beijing tiantan hospital

Beijing, China, 100070

Actively Recruiting

Loading map...

Research Team

Y

Yongjun Wang

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here